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NCT06947538NARecruiting

Stepped Care for Posttraumatic Stress Disorder Study

Boston Medical Center

Start Date

3/12/2026

Completion Date

6/1/2029

Summary

Less than 20% of people with PTSD receive any treatment. This study extends a program of research by the investigator focused on developing adaptive (stepped) interventions for PTSD. The adaptive intervention sequences a digital mental health intervention (DMHI) and brief trauma- and skills-focused treatments for PTSD. The selected treatments are brief and scalable and less burdensome to systems of care. These treatments are: web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), Brief STAIR, and Written Exposure Therapy (WET).

Detailed Description

This study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design. At baseline, participants are randomized to Stage 1 Treatments, either webSTAIR (self-managed) or webSTAIR plus community health worker coaching. At 8 weeks, stage 1 nonresponders are re-randomized to Stage 2 clinician-administered treatments, either Brief STAIR or WET. Nonresponse is defined as less than a 15-point decrease in PTSD symptom severity from baseline, as measured by the PTSD Checklist for DSM-5 (PCL-5). The objectives of this study are to: * examine the main effects of stage 1 treatments, stage 2 treatments, and embedded * adaptive interventions on PTSD symptom severity. * confirm mechanisms of change established in the extant PTSD literature * identify patient-level moderators of change in PTSD symptoms severity at 18 weeks

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion criteria: Assessed at pre-screening * Boston Medical Center primary care patient * At least 18 years of age * Access to computer or mobile device * Able to receive treatments in English or Spanish * Able to read at 4th grade level Assessed at baseline * Endorsement of Criterion A trauma using the Life Events Checklist for the DSM-5 (LEC-5), assessed at baseline * PTSD diagnosis, confirmed by the Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) assessed at baseline \- Concordance between CAPS-5 and PCL-5 at baseline * Clinically appropriate for outpatient level of care * Stable on psychotropic medication for \>4 weeks Exclusion criteria: Assessed at pre-screening • Patient is currently engaged in clinician-administered therapy Assessed at baseline (clinician interview) * Patient is not clinically appropriate for outpatient level of care. * Acute risk for suicidal thoughts or behaviors, assessed by the Columbia Suicide Severity Rating Scale, administered by research clinician at baseline.

Interventions

BEHAVIORAL

webSTAIR

BEHAVIORAL

WebSTAIR plus coaching

BEHAVIORAL

Clinician administered Brief STAIR

BEHAVIORAL

Clinician administered WET

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Conditions

Post Traumatic Stress Disorder

Locations

Boston Medical Center

Boston, Massachusetts 02118

United States